RecruitingNCT03775330

Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases

Parallel Prospective Observational Cohorts Evaluating Stereotactic Radiosurgery Alone (SRS) and Whole Brain Radiotherapy (WBRT) Plus SRS for Patients With 5 to 30 Brain Metastases


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

126 participants

Start Date

Oct 20, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

This clinical study is a parallel, prospective observational single-centre trial in patients presenting with 5 to 30 brain metastases. Patients to receive either stereotactic radiosurgery (SRS) alone or SRS plus whole brain radiation (WBRT) will be enrolled.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for treating patients who have 5 or more tumors that have spread to the brain (brain metastases): targeted radiation (called stereotactic radiosurgery or SRS) aimed precisely at each tumor, versus SRS combined with whole-brain radiation. The goal is to find which approach best controls the cancer while preserving memory and mental function. **You may be eligible if...** - You have been diagnosed with a solid cancer (not blood cancer or certain aggressive types like small cell lung cancer) that has spread to the brain - You have between 5 and 30 brain metastases seen on a recent MRI - You are 18 years or older - You are in reasonably good physical condition (able to perform daily activities) **You may NOT be eligible if...** - You have a blood cancer or certain types like small cell carcinoma or germ cell cancer - You have more than 50 brain metastases - You have had prior whole-brain radiation - Your physical condition is too poor to tolerate the treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Radiosurgery (SRS)

SRS or hypofractionated stereotactic radiation delivered via the Leksell Gammknife Perfexion/Icon radiosurgery system. Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions or 24-27 Gy in 3 fractions at the discretion of the radiation oncologist Maximum diameter of metastasis (doses in single fraction): ≤ 2 cm: 15-20 Gy \> 2 cm and ≤ 3 cm: 15-18 Gy \> 3 cm and ≤ 4 cm: 15 Gy Tumour location (doses in single fraction): Brainstem: 15 Gy Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions may be used for lesions \> 2 cm at the discretion of the radiation oncologist Note: SRS dosing reduced by 20% (for all prescriptions \> 15 Gy) when patient is randomized to SRS + WBRT arm

RADIATIONWhole brain radiation (WBRT)

WBRT 20 Gy in 5 fractions or 30 Gy in 10 fractions at the discretion of the radiation oncologist


Locations(1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

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NCT03775330


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